BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3874774 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00583
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE FITTING MALE LUER LOCK (0103-00-0398-01). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. NO PATIENT INJURY WAS REPORTED. (B)(4).

    Description of Event or Problem · 1

    DURING A SAFETY DISK LEAK CHECK OF THE IABP, THE CUSTOMER OBSERVED THAT THE IABP FAILED THE SAFETY DISK LEAK TEST. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250437 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1